MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINER LIPPED 36MM ID GROUP 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	132-36-52
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Muscle Weakness/Atrophy (1967); Pain (1994); Synovitis (2094); Discomfort (2330); Insufficient Information (4580)
Date of Event	10/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): (b)(6), 164-01-14 - element-stem, collarless w/ha, std offset, sz 14.(b)(6), 170-36-00 - biolox delta femoral head 36mm od, +0mm.(b)(6), 180-01-54 - nv crown cup clstr hole 54mm group 2.
Event or Problem Description
As reported, approximately 4 years post op initial right tha, this 55 y/o male patient was revised.The patient presented to surgeons office with complaints of their total hip.The polyethylene hip liner implant was a gxl recalled liner showing wear on imaging.The patient was scheduled for a hip revision possible head and liner exchange.During the revision surgery, the femoral head was removed and the gxl recalled liner was removed.A new vitamin e xle hip liner was implanted along with a new femoral head implant.Patient was last known to be in stable condition following the event.Device is not returning - the implants were sent to the lab and legal at the hospital.
Additional Manufacturer Narrative
H3: based on the available information, the patient involved meets the following risk criteria for early prosthesis wear as specified in the hhe: combination of largest available femoral head and/or thinnest available acetabular liner was used.The most likely underlying cause for the revision due to early prosthesis wear reported is a combination of risk factors specified in the hhe.However, this cannot be confirmed from the reported information and the devices were not available for evaluation.
Additional Manufacturer Narrative
The following sections have corrected information: h6: health effect clinical code, type of investigation, investigation conclusions.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6 - health effect - clinical code.

• Brand Name: NV GXL LINER LIPPED 36MM ID GROUP 2
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18110372
• Report Number: 1038671-2023-02746
• Device Sequence Number: 5556744
• Product Code: JDI
• UDI-Device Identifier: 10885862207036
• UDI-Public: 10885862207036
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K121392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/26/2023
• Device Catalogue Number: 132-36-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 03/04/2024; 11/18/2024; 03/21/2025
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 03/21/2024; 12/11/2024; 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1732-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Patient Age: 55 YR
• Patient Sex: Male